Verification of the sialagogic effect in food

UMIN ID: UMIN000030001

Registered date:01/04/2019

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: healthy humans
• Date of first enrollment: 2017/11/20
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

1. Single oral ingestion of the water (10-20ml) 2. Intake of the water (500ml/day) for 2 weeks
Single oral ingestion of the test food A (10-20ml)
Single oral ingestion of the test food B (10-20ml)
1. Single oral ingestion of the test food C (10-20ml) 2. Intake of test food C (under 30ml /day) for 2 weeks
Single oral ingestion of the test food C+D (10-20ml)
1. Single oral ingestion of the test food D (10-20g) 2. Intake of test food D (under 30g/day) for 2 weeks

Outcome(s)

• Primary Outcome: Blood flow in salivary gland (NIRS) Amount of saliva secretion
• Secondary Outcome: Biochemical analysis (saliva) alpha-Amylase Hemoglobin LDH sIgA Lysozyme Bacteria test

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1) Subjects who has treatment with warfarin. (2) Subjects with the severe disease medical history. (3) Subjects who are judged as inappropriate to be enrolled in this trials by chief investigator or sub investigators

Related Information

• Primary Sponsor: Prefectural University of Hiroshima.
• Secondary Sponsor: SAPPORO HOLDINGS LTD.
• Source(s) of Monetary Support: Prefectural University of Hiroshima.